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New generic for long-acting opioid analgesic Hysingla® ER – hydrocodone bitartrate extended-release tablet – now on the market

April 28, 2021 · Clinical Team

The generic formulation of Hysingla® ER, hydrocodone bitartrate extended-release (ER) tablets, was released in March 2021 according to the U.S. Food and Drug Administration (FDA). Hysingla ER is FDA-approved for the treatment of severe pain in patients who require daily, around-the-clock, long-term opioid analgesic treatment.

Now that generic Hysingla ER (hydrocodone bitartrate ER tablet) is available, it is important to understand some of the differences and similarities with the generic for Zohydro® ER (hydrocodone bitartrate ER capsule), to avoid confusion and potential prescribing errors.

Abuse-deterrent differences

hydrocodone bitartrate ER tablets

Brand-name Hysingla ER was originally approved by the FDA as an abuse-deterrent opioid analgesic. According to the FDA, the generic hydrocodone bitartrate ER tablets is also approved with abuse-deterrent properties.

hydrocodone bitartrate ER capsules

In contrast, although Zohydro ER was reformulated several years after it was originally approved to exhibit some abuse-resistant properties in the capsule, the FDA did not approve an abuse-deterrent labeling claim for Zohydro ER or its generic hydrocodone bitartrate ER capsule.

As with all abuse-deterrent formulations of opioid analgesics, there is still a potential for abuse and misuse, which can lead to overdose and death. For more information on abuse-deterrent opioid analgesics, click here.

Dosage differences

Tablet formulation
e.g., Hysingla ER and its generic
  Capsule formulation
e.g., Zohydro ER and its generic
Take once daily (every 24 hours) Dose guidelines Take two times per day (every 12 hours)
20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg Available strengths 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg 



Hydrocodone bitartrate ER formulation similarities

The hydrocodone bitartrate ER formulations

  • Are long-acting opioid analgesics not recommended as first-line treatment for chronic pain according to treatment guidelines.
  • Are only recommended for use in patients who have failed and/or not tolerated non-opioid analgesics or short-acting opioid analgesics.
  • Are not approved for acute pain or as needed (prn) pain relief.
  • Do not contain non-opioid medications, including but not limited to, acetaminophen or ibuprofen.
  • Carry the same risks associated with prescribing opioid analgesics, irrespective of the formulation.  
     

Impact on workers’ comp and auto no-fault industry

Regardless of whether the hydrocodone bitartrate ER tablet or capsule formulation is prescribed for a claimant, this long-acting opioid analgesic should not be considered first-line for the treatment of chronic pain. Claims professionals should always review the claimant’s complete medical and medication history and determine if other medications, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), short-acting opioid analgesics and other long-acting opioid analgesics have been tried prior to initiating hydrocodone bitartrate ER tablets or capsules.

As determined by our Pharmacy and Therapeutics (P&T) Committee, all hydrocodone bitartrate ER formulations require prior authorization on our global workers’ compensation, auto and standard injury-based formularies.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

 

Sources:
1.  U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=208269#350. Accessed on April 12, 2021
2. U.S. Food and Drug Administration. Abuse-Deterrent Opioid Analgesics. Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/abuse-deterrent-opioid-analgesics. Accessed on April 12, 2021.
3. ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. Accessed on April 12, 2021.
4. Hysingla ER (hydrocodone extended-release tablet) [package insert]. Stamford, CT: Purdue Pharma L.P.; March 2021. Available at https://hysinglaer.com/. Accessed on April 13, 2021.
5. Zohydro ER (hydrocodone extended-release capsule) [package insert]. Morristown, NJ: Currax Pharmaceuticals LLC; March 2021. Accessed on April 13, 2021.

 


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